Posted June 23, 2020

KBMO Diagnostics Warned for Unapproved COVID-19 Test

On June 17, the FDA issued a warning letter to KBMO Diagnostics, LLC for selling the product COVID-19 Fingerstick Test Kit, an unapproved, adulterated and misbranded antibody test for coronavirus (COVID-19). The agency also emphasized to consumers that there are no diagnostic or antibody COVID-19 test kits that are authorized, cleared or approved to be used completely at home.

The test kits were being sold in the US directly to consumers for at-home use without FDA authorization. Additionally, the KBMO Diagnostics website falsely suggests that products are FDA-approved by bearing the FDA logo, which is for the official use by the FDA only, and not for use on private sector materials.

An FDA director has previously spoken out against companies committing fraud to take advantage of the pandemic, stating, "When tests are marketed inappropriately, with inaccurate or misleading claims -- such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not -- they put the health of Americans at risk. Such conduct will not be tolerated by the FDA, and we will continue to monitor tests marketed in the U.S., taking appropriate action as warranted." 

See ConsumerLab's answer to the question How can I get tested for the coronavirus? Can I get a home-test for COVID-19? Which are the best tests? Are any tests free?

See Related Warnings:

FDA Warns Companies Selling Unapproved COVID-19 Tests

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FDA Warns Sellers of CBD, Colloidal Silver, Essential Oils, and More Promoted to Treat Coronavirus

Seller of Vitamin and CBD "NoronaPak" Warned for Coronavirus Claims

FTC Warns 50 More Companies for Coronavirus Claims

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